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Sr Quality Systems Spec

Carlsbad, CA 92008

Posted: 01/24/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 598530 Is job remote?: No Country: United States

Job Description

  1. CAPA Management & Root Cause Analysis Tools
  2. Technical writing skillset – experience writing and reviewing QMS related documentation for ISO 13485 and EU MDR compliance
  3. Product Service Quality experience preferred


Education Required: Bachelors Degree

Years’ Experience Required: 5 years

Responsibility to provide technical guidance and quality compliance for various Respiratory related products including ventilators, breathing systems, airways devices and airway management devices. You will work in partnership with the R&D and OU Quality Teams, to maintain compliant quality systems and help develop improved strategies for quality. This will allow our company to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.

This role will be within the Respiratory Interventions (RI) Operating Unit

RESPIRATORY INTERVENTIONS (RI), a division of MITG, offers a portfolio of innovative solutions that spans the continuum of care. We focus on expanding global access to our therapies that improve clinical outcomes for patients with respiratory compromise.

While the global crisis develops daily, our purpose remains the same: To prevent the onset and improve the management of respiratory failure. This guiding principle has enabled us to support patients and clinicians, while creating new opportunities for growth.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

The Senior Quality Engineer develops and maintains quality assurance programs to ensure that the performance and quality of company products conform to established standards and agency  guidelines.  Primary job responsibilities include CAPA management, audit program management and Quality Management System improvements.

Responsibilities may include the following and other duties may be assigned.
  • Provides oversight for the maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Provides expertise and guidance in complying with policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.
  • Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
  • Coordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Responsible for planning, organizing, and editing a variety of RFAIs associated with software, hardware, labeling, post-market vigilance and technical documentation.  Coordinate interactions with worldwide competent authorities, notified bodies and international government authorities.
  • Drive Quality Management System (QMS) & product continuous improvement through CAPA management.  Elevate issues to management as appropriate.
  • Coach new CAPA owners through processes and best practice.
  • Develop and maintain Compliance policies supporting the Risk Management program.
  • Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
  • Lead process improvement projects and assessment of quality plans.
  • Support Management during external/internal inspections and participate in the management of external/internal inspections.
  • Assist with external/internal audit preparation and responses to external / internal audit observations.
  • Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on the company's operations.

Must Have: Minimum Requirements
  • Bachelor’s Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
  • Expertise in CAPA compliance & investigation techniques.
  • Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
  • Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.
  • Must work well in cross-functional teams and be a self-starter.
  • Excellent written and verbal communication skills.
  • Excellent organizational skills.
  • Computer literacy must include proficiency with MS Office and experience with networks and applications.

Nice to Have
  • Master’s degree in Engineering, Program Management, or Compliance
  • Lead Auditor Certification to ISO 13485:2016
  • ASQ CQE, CQA, CSQE and/or CRE certification.
  • Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
  • Familiar with IEC 60601 and product specific industry standards.
  • Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
  • Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues. 
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